Trial Outcomes & Findings for To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects (NCT NCT04018313)
NCT ID: NCT04018313
Last Updated: 2023-05-11
Results Overview
Area Under the concentration-time Curve from time zero to infinity (AUC0-inf) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
176 participants
Primary outcome timeframe
up to day 127
Results posted on
2023-05-11
Participant Flow
Participant milestones
| Measure |
CT-P39 (Part 1)
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 1)
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
CT-P39 (Part 2)
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
47
|
49
|
50
|
|
Overall Study
COMPLETED
|
14
|
14
|
46
|
47
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Baseline characteristics by cohort
| Measure |
CT-P39 (Part 1)
n=15 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 1)
n=15 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
CT-P39 (Part 2)
n=47 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=49 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=50 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 6.31 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 9.11 • n=7 Participants
|
28.2 years
STANDARD_DEVIATION 8.81 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 11.65 • n=4 Participants
|
30.3 years
STANDARD_DEVIATION 10.09 • n=21 Participants
|
29.6 years
STANDARD_DEVIATION 9.99 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
101 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
134 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Australian Aborigine/Torres Strait Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
138 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Region of Enrollment
Australia
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
47 participants
n=5 Participants
|
49 participants
n=4 Participants
|
50 participants
n=21 Participants
|
176 participants
n=8 Participants
|
|
Body mass index at screening
|
22.93 kg/m2
STANDARD_DEVIATION 2.525 • n=5 Participants
|
23.65 kg/m2
STANDARD_DEVIATION 2.306 • n=7 Participants
|
23.90 kg/m2
STANDARD_DEVIATION 3.042 • n=5 Participants
|
23.19 kg/m2
STANDARD_DEVIATION 2.864 • n=4 Participants
|
23.71 kg/m2
STANDARD_DEVIATION 2.980 • n=21 Participants
|
23.54 kg/m2
STANDARD_DEVIATION 2.866 • n=8 Participants
|
PRIMARY outcome
Timeframe: up to day 127Population: PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab.
Area Under the concentration-time Curve from time zero to infinity (AUC0-inf) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Outcome measures
| Measure |
CT-P39 (Part 2)
n=46 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=49 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=50 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection
|
US-licensed Xolair (Part 2)
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
|
910.9 day*μg/mL
Standard Deviation 278.57
|
897.7 day*μg/mL
Standard Deviation 270.25
|
926.3 day*μg/mL
Standard Deviation 273.30
|
—
|
—
|
PRIMARY outcome
Timeframe: up to day 127Population: PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab.
Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Outcome measures
| Measure |
CT-P39 (Part 2)
n=47 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=49 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=50 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection
|
US-licensed Xolair (Part 2)
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Outcome Measures [AUC0-last] for Part 2
|
846 day*μg/mL
Standard Deviation 251.87
|
843.8 day*μg/mL
Standard Deviation 248.04
|
850.0 day*μg/mL
Standard Deviation 213.13
|
—
|
—
|
PRIMARY outcome
Timeframe: up to day 127Population: PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab.
Maximum serum concentration (Cmax) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Outcome measures
| Measure |
CT-P39 (Part 2)
n=47 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=49 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=50 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection
|
US-licensed Xolair (Part 2)
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Outcome Measures [Cmax] for Part 2
|
20.08 μg/mL
Standard Deviation 5.9940
|
18.24 μg/mL
Standard Deviation 4.9981
|
19.43 μg/mL
Standard Deviation 5.4159
|
—
|
—
|
SECONDARY outcome
Timeframe: up to day 127Population: PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab.
To assess Time to Cmax (Tmax) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Outcome measures
| Measure |
CT-P39 (Part 2)
n=15 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=15 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=47 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=49 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection
|
US-licensed Xolair (Part 2)
n=50 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2
|
7.178 day
Interval 5.04 to 56.27
|
7.244 day
Interval 3.0 to 14.17
|
7.098 day
Interval 2.0 to 14.26
|
7.306 day
Interval 3.0 to 18.26
|
7.183 day
Interval 3.0 to 21.17
|
SECONDARY outcome
Timeframe: up to day 127Population: PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab.
To assess Terminal half-life (t1/2) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Outcome measures
| Measure |
CT-P39 (Part 2)
n=15 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=15 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=46 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=49 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection
|
US-licensed Xolair (Part 2)
n=50 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2
|
29.75 day
Standard Deviation 3.9477
|
28.77 day
Standard Deviation 5.0315
|
29.30 day
Standard Deviation 9.5158
|
27.69 day
Standard Deviation 5.5603
|
28.63 day
Standard Deviation 6.6290
|
SECONDARY outcome
Timeframe: up to day 127Population: PD set: all randomly assigned subjects who receive a complete dose of study drug and have at least one post-treatment free IgE or total IgE concentration above the lower limit of quantification.
To assess the minimum observed concentration (Cmin) of Free IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Outcome measures
| Measure |
CT-P39 (Part 2)
n=13 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=11 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=31 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=38 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection
|
US-licensed Xolair (Part 2)
n=32 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
|---|---|---|---|---|---|
|
Pharmacodynamics Outcome Measures [Cmin of Free IgE] for Part 1 & Part 2
|
3.1538 IU/mL
Standard Deviation 1.12963
|
3.4613 IU/mL
Standard Deviation 1.43457
|
3.5267 IU/mL
Standard Deviation 1.45275
|
3.5590 IU/mL
Standard Deviation 1.56235
|
3.7002 IU/mL
Standard Deviation 1.69613
|
SECONDARY outcome
Timeframe: Up to day 127Population: PD set: all randomly assigned subjects who receive a complete dose of study drug and have at least one post-treatment free IgE or total IgE concentration above the lower limit of quantification.
To assess the Time to Cmin (Tmin) of Free IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Outcome measures
| Measure |
CT-P39 (Part 2)
n=13 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=11 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=31 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=38 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection
|
US-licensed Xolair (Part 2)
n=32 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
|---|---|---|---|---|---|
|
Pharmacodynamic Outcome Measures [Tmin of Free IgE] for Part 1 & Part 2
|
3.000 day
Interval 0.5 to 10.09
|
5.196 day
Interval 1.0 to 126.25
|
3.000 day
Interval 0.25 to 21.21
|
5.051 day
Interval 0.25 to 70.17
|
3.002 day
Interval 0.25 to 41.07
|
SECONDARY outcome
Timeframe: up to day 127Population: PD set: all randomly assigned subjects who receive a complete dose of study drug and have at least one post-treatment free IgE or total IgE concentration above the lower limit of quantification.
To assess the maximum observed concentration (Cmax) of total IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Outcome measures
| Measure |
CT-P39 (Part 2)
n=15 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=15 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=46 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=49 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection
|
US-licensed Xolair (Part 2)
n=49 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
|---|---|---|---|---|---|
|
Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2
|
241.5333 IU/mL
Standard Deviation 156.50234
|
165.2000 IU/mL
Standard Deviation 122.59702
|
245.2391 IU/mL
Standard Deviation 223.24856
|
174.2857 IU/mL
Standard Deviation 145.17432
|
219.5714 IU/mL
Standard Deviation 187.41287
|
SECONDARY outcome
Timeframe: up to day 127Population: PD set: all randomly assigned subjects who receive a complete dose of study drug and have at least one post-treatment free IgE or total IgE concentration above the lower limit of quantification.
To assess the Time to Cmax (Tmax) of total IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Outcome measures
| Measure |
CT-P39 (Part 2)
n=15 Participants
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=15 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=46 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=49 Participants
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection
|
US-licensed Xolair (Part 2)
n=49 Participants
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL Solution for injection.
|
|---|---|---|---|---|---|
|
Pharmacodynamic Outcome Measures [Tmax of Total IgE] for Part 1 & Part 2
|
28.263 day
Interval 20.99 to 69.17
|
28.167 day
Interval 14.19 to 56.1
|
28.191 day
Interval 3.0 to 70.13
|
28.156 day
Interval 14.01 to 71.07
|
28.087 day
Interval 10.18 to 73.07
|
Adverse Events
CT-P39 (Part 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
EU-approved Xolair (Part 1)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CT-P39 (Part 2)
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
EU-approved Xolair (Part 2)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
US-licensed Xolair (Part 2)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-P39 (Part 1)
n=15 participants at risk
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 1)
n=15 participants at risk
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
CT-P39 (Part 2)
n=47 participants at risk
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=49 participants at risk
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=50 participants at risk
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL, Solution for injection.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
2.1%
1/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
Other adverse events
| Measure |
CT-P39 (Part 1)
n=15 participants at risk
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 1)
n=15 participants at risk
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
CT-P39 (Part 2)
n=47 participants at risk
Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS).
CT-P39: 150 mg/mL Solution for injection.
|
EU-approved Xolair (Part 2)
n=49 participants at risk
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
|
US-licensed Xolair (Part 2)
n=50 participants at risk
Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS).
US-licensed Xolair: 150 mg/mL, Solution for injection.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
12.8%
6/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
4.1%
2/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
4.0%
2/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
General disorders
Catheter site pain
|
6.7%
1/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
6.7%
1/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
2.0%
1/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
6.0%
3/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
General disorders
Fatigue
|
6.7%
1/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
6.4%
3/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
4.1%
2/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
6.0%
3/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
General disorders
Injection site reaction
|
6.7%
1/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
6.7%
1/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
17.0%
8/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
10.2%
5/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
12.0%
6/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
4.1%
2/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
8.0%
4/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
General disorders
Catheter site irritation
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
2.1%
1/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
2.0%
1/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
6.0%
3/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
8.0%
4/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
6.7%
1/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
2.1%
1/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
8.2%
4/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
4.0%
2/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
33.3%
5/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
23.4%
11/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
20.4%
10/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
30.0%
15/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
2.1%
1/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
2.0%
1/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
8.0%
4/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
2.1%
1/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
2.0%
1/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
6.0%
3/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/15 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
0.00%
0/47 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
8.2%
4/49 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
4.0%
2/50 • All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
|
Additional Information
Keumyoung Ahn/Head of Clinical Planning 2 Department
Celltrion. Inc
Phone: +82 32 850 4190
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A confidentiality and non-disclosure agreement (CDA) was executed between Celltrion, Inc. and some PIs who have participated in publications funded by the sponsor for academic purposes for a period that is more than 180 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER